MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-28 for CELL SAVER ELITE LN CSE-E-US MACHINE CSE-E-US manufactured by Haemonetics Corporation.
[176628270]
The intraoperative process went smoothly except for a higher than expected blood loss (1000mls). All machine processing and washing etc went well with no mechanical issues. No messages were displayed on device. Adequate anticoagulation and wash volume were utilized. The device was taken out of service.
Patient Sequence No: 1, Text Type: N, H10
[176628271]
On 12-december-2019 haemonetics was informed of a patient fatality which occurred on (b)(6) 2017 using a cell saver elite machine. The patient fatality occured post-operation procedure for removal of fibroids. Near the end of the procedure anesthesia stated that the patient was having some hemodynamic instability and the instability occurred shortly after the infusion of cell saver washed product. Patient received approx. 300 ml of 400 ml available for reinfusion of washed cells. The patient expired later that night/early morning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1219343-2020-00003 |
| MDR Report Key | 9638155 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-01-28 |
| Date of Report | 2019-12-12 |
| Date of Event | 2017-08-21 |
| Date Mfgr Received | 2019-12-12 |
| Device Manufacturer Date | 2012-03-12 |
| Date Added to Maude | 2020-01-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR SHAUN FLANAGAN |
| Manufacturer Street | 125 SUMMER STREET |
| Manufacturer City | BOSTON MA 02110 |
| Manufacturer Country | US |
| Manufacturer Postal | 02110 |
| Manufacturer G1 | HAEMONETICS CORPORATION |
| Manufacturer Street | 125 SUMMER STREET |
| Manufacturer City | BOSTON MA 02110 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02110 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CELL SAVER ELITE |
| Generic Name | CELL SAVER ELITE |
| Product Code | CAC |
| Date Received | 2020-01-28 |
| Model Number | LN CSE-E-US MACHINE |
| Catalog Number | CSE-E-US |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAEMONETICS CORPORATION |
| Manufacturer Address | 125 SUMMER STREET BOSTON MA 02110 US 02110 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-01-28 |